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Completed

NCT Number: NCT02563639

Apixaban in Atrial Fibrillation Registry

Objective of the registry is to assess the use of antithrombotic therapies and adherence to guidelines in patients with non-valvular atrial fibrillation.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Ludwigshafen

Ludwigshafen, D-67063, Germany

About this study

Atrial fibrillation (AF) confers a substantial risk of mortality and morbidity from stroke and thromboembolism, and this common cardiac arrhythmia represents a major healthcare burden in Europe. Stroke prevention is central to the management of AF patients, with oral anticoagulation (OAC) using well-controlled adjusted dose vitamin K antagonists or novel OACs being recommended for patients with AF with ≥1 stroke risk factors. Also, the 2012 focused update of the ESC guidelines strongly advocates a clinical practice shift so that the initial decision step now is the identification of 'truly low risk' patients, essentially those age<65 without any stroke risk factors (both male and female), who do not need any antithrombotic therapy. The ESC guidelines only recommend use of the CHA2DS2-VASc score for stroke risk assessment, and the 'low risk' patients are defined as those with a CHA2DS2-VASc score=0 (males) or score=1 (females). Subsequent to this initial step of identifying the low risk patients, effective stroke prevention (which is essentially OAC) can then be offered to AF patients with ≥1 stroke risk factors, with treatment decisions made in consultation with patients and incorporating their preferences. Despite these recommendations, a substantial number of patients with AF is not treated with OAC. On the other hand, patients with AF and low risk are being "overtreated", receiving OAC despite a CHADS-VASc score of 0. Therefore, this registry will determine, if patients with non-valvular AF are treated ac-cording to current guidelines.

Apixaban is an oral factor Xa inhibitor, which has been tested in a number of indications. In the AVERROES study in patients with non-valvular atrial fibrillation deemed not suitable for treatment with a vitamin-K antagonist apixaban compared to aspirin reduced the incidence of stroke and systemic embolism without increasing bleeding complications. In the large ARISTOTELE study apixaban was superior to warfarin, it re-duced the primary endpoint of stroke and systemic embolism caused less bleeding and reduced all-cause mortality. Subsequently apixaban has been approved by the European health authorities for the use in patients with atrial fibrillation. It is therefore of interest to determine use of apixaban in real life with respect to patient selection, adherence to therapy and midterm efficacy and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years
  • Non-valvular atrial fibrillation
  • In hospitals or specialized or non-specialised office-based centres
  • Written informed consent for participation in observational study (incl. telephone follow-ups)
  • Not simultaneously participating in any randomized trial

Exclusion criteria

No exclusion criteria

Treatment and study plan

Primary outcomes

  1. Comparison of antithrombotic therapy for atrial fibrillation: Prescribed drugs

    Time frame: 12 months

    Name of antithrombotic drug

Secondary outcomes

  1. Safety of Apixaban as assessed by MACCE, Haemorrhagic complications, Ischemic clinical events, Stroke, Systemic embolism, Hospitalisations for stroke, cardiac reasons or bleeding complications

    Time frame: 12 months

    • MACCE (death / MI / stroke)
    • Haemorrhagic complications (major / minor bleeding)
    • Ischemic clinical events (non-fatal MI, cardiac death, etc.)
    • Stroke (ischemic, haemorrhagic)
    • Systemic embolism
    • Hospitalisations for stroke, cardiac reasons or bleeding complications
  2. Subjective Quality of Life

    Time frame: 12 months

    Questionnaire (EQ-5D-5L)

  3. Comparison of antithrombotic therapy for atrial fibrillation: Dose of drugs

    Time frame: 12 months

    Dose of antithrombotic drug

  4. Comparison of antithrombotic therapy for atrial fibrillation: Duration of treatment

    Time frame: 12 months

    Duration of treatment [months]

  5. Comparison of antithrombotic therapy for atrial fibrillation: Contraindications for anticoagulation

    Time frame: 12 months

    Relative and absolute contraindications to anticoagulation at baseline and history

  6. Comparison of antithrombotic therapy for atrial fibrillation:Selection of anticoagulant

    Time frame: 12 months

    Basis for the selection of the anticoagulant

Sponsors and collaborators

Lead sponsor

IHF GmbH - Institut für Herzinfarktforschung

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

APAF Apixaban in Atrial Fibrillation Registry

Acronym: APAF

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Sep 30, 2015
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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